Endoscope for direct visualization of the spine and epidural space

• US 5,396,880 A
• Filed: 04/08/1992
• Issued: 03/14/1995
• Est. Priority Date: 04/08/1992
• Status: Expired due to Term

• Current Assignee: SDGI Holdings Incorporated (Medtronic Plc)
• Original Assignee: Danek Medical, Inc. (Medtronic Plc)
• Inventors: Kagan, Jonathan, Brumfield, David L., White, Roger
• Primary Examiner(s): Apley, Richard J.
• Assistant Examiner(s): Leubecker, John P.
• Application Number:
  US07/865,349
• Time in Patent Office: 1,070 Days
• Field of Search: 128/656, 128/657, 128/658, 128/4, 128/6, 128/7, 128/8, 128/772, 604/95, 604/280, 604/21, 385/117, 385/118, 606/106, 606/160, 606/164
• US Class Current: 600/109
• CPC Class Codes: A61B 1/0051 with controlled bending of insertion part
• CPC Class Codes: A61B 1/042 characterised by a proximal camera, e.g. a CCD camera
• CPC Class Codes: A61B 1/3135 for examination of the epidural or the spinal space
• CPC Class Codes: A61B 5/032 Spinal fluid pressure

Abstract

A system for direct visualization of the spine and the epidural and/or intra-discal space to facilitate diagnosis and treatment of spinal conditions and that is adapted for percutaneous introduction into the spinal space. The system includes a disposable flexible catheter, a fiber-optic bundle disposed within the catheter which is connected to a light source and camera. The bundle is removably and adjustably connected to the proximal end of the catheter to permit rotation of the bundle relative to the catheter. A mechanism for controllably deflecting the tip of the catheter is provided to vary the viewing angle of the fiber-optic bundle within and to assist in steering the catheter through the spinal space. The mechanism includes a deflection wire extending through the catheter and affixed at the distal end thereof. The proximal end of the deflection wire is affixed to a sleeve which is slidably disposed around the catheter and within a housing. The housing includes an internal flange that defines a stop surface which is contacted by the sleeve as the catheter and deflection wire is moved in a first direction. After the sleeve contacts the stop surface, further movement of the catheter in the first direction causes tension in the wire between the sleeve and the wire'"'"'s securement to the catheter, thereby bending the catheter tip in the direction of the securement. The catheter can be rotated with the tip in its deflected position to provide a conical viewing region within the spinal space.

Claims

1. A system for direction visualization of the spinal epidural or intra-discal space comprising:

a disposable flexible catheter sized for percutaneous introduction into the spinal space, said catheter having a proximal end and a distal end for insertion into the spinal space and including a first channel extending along the entire length of the catheter and a tip adjacent the distal end;

a fiber-optic bundle sized to be removably slidably received within said first channel, said bundle having a proximal end and a distal end, and including imaging fibers and light fibers for connection to a camera and a light source, respectively;

connection means at the proximal end of said catheter for connecting said fiber-optic bundle to the proximal end of said catheter and for adjustably positioning the distal end of said bundle relative to the distal end of said catheter;

tip deflection means separate from said fiber-optic bundle for controllably defecting said tip of said catheter when the distal end is in the spinal space; and

irrigation means for providing irrigation fluid through said catheter to the distal end of said catheter.

2. The system of claim 1, where said tip has a length dimension of less than about 2.5 cm measured from the distal end of said catheter.

3. The system of claim 1, wherein said catheter has an outer diameter of less than about 2.75 mm.

4. The system of claim 1, wherein said first channel is semi-circular.

5. The system of claim 1, further comprising radio-opaque means at the distal ends of said catheter mid said fiber-optic bundle for permitting radiographic verification of the relative position of the distall end of said brindle to the distal end said catheter.

6. The system of claim 1, wherein said tip deflection means includes:

a deflection wire having a first end and a second end and having a first portion adjacent said first end disposed outside said catheter and a second portion between said first portion and said second end extending throu gh said catheter;

means for securing said second end of said deflection wire to said catheter at the distal end thereof;

means for moving said catheter in a first direction from the proximal end toward the distal end of said catheter; and

means for restraining said first end of said deflection wire against movement in said first direction as said catheter is moved in said first direction, whereby said deflection wire is placed in tension as it is pulled at its second end by said catheter to thereby cause said tip so deflect in the direction of said means for securing.

7. The system of claim 6, wherein said catheter includes a second channel and a slot opening into said second channel through which said second portion of said deflection wire extends.

8. The system of claim 6 wherein said means for moving includes means for limiting movement of said catheter in said first direction relative to said means for restraining to thereby control the amount of deflection of said tip.

9. The system of claim 8, wherein said means for limiting movement of said catheter in said first direction relative to said means for restraining is sufficient to deflect said tip between 0°

and about 90°

.

10. The system of claim 6, wherein said memos for moving said catheter includes means for rotating said catheter with the tip deflected,

11. The system of claim 6, wherein said means for restraining includes:

an enlogated housing defining a cavity therein, said housing having openings at its ends for slidably receiving said catheter therethrough;

a sleeve within said cavity and slidably disposed about said catheter;

means for connecting said first end of said deflection wire to said sleeve; and

said housing further defining a stop surface in said cavity for restraining movement of said sleeve in said first direction.

12. system of claim 11 wherein said means for moving includes means for limiting movement of said catheter in said first tirection relative to said means for restraining to thereby control the amount of deflection of said tip.

13. The system of claim 12, wherein said means for limiting movement includes:

a first stop connected to said catheter and slidably disposed within said cavity;

and

a pin affixed to said housing and projecting into said cavity between said first stop and said sleeve,

whereby said first stop contacts said pin when said catheter is moved in said first direction.

14. The system of claim 11, wherein initial contact between said sleeve and said stop surface defines a first position and initial contact between said first stop and said pin defines a second position so that displacement of said catheter between said first position and said second position will result in tip deflection of between 0°

and about 90°

.

15. The system of claim 13, wherein said means for limiting movement further includes a second stop connected to said catheter and slidably disposed within said cavity between said pin and said sleeve, whereby said second stop contacts said pin when said catheter is moved in a second direction opposite said first direction.

16. The system of claim 6, wherein said means for securing includes:

a tube affixed at the distal end of said catheter and having an end opening beyond the distal end of said catheter; and

second means for securing said second end of said deflection wire to said tube at said end opening.

17. The system of claim 16, wherein second means for securing includes a ring engaged to the interior of said tube at said end opening and beyound the distal end of said catheter said deflection wire being affixed to said ring.

18. The system of claim 16, wherein said catheter includes a second channel and a slot opening into said second channel through which said second portion of said deflection wire extends.

19. The system of claim 18, wherein said second channel terminates short of the distal end of the catheter and said catheter has a reduced outer dimension from the end of said second channel to the distal end of said catheter with said deflection wire extending from the end of said second channel adjacent the reduced outer dimension within said tube.

20. The system of claim 1, wherein said connection means includes:

clamp means for clamping said fiber-optic bundle; and

means for adjusting the length distance between the distal end of said catheter and said clamp means.

21. The system of claim 20, wherein said connection means further includes rotation means for rotating said fiber-optic bundle relative to said catheter.

22. A system for direct visualization of the spinal epidural or intra-discal space comprising:

a disposable flexible catheter sized for percutaneous introduction into the spinal space, said catheter having an outer diameter of less than about 2.75 mm, said catheter having a proximal end a distal end for insertion into the spinal space and including a first channel extending along the entire length of the catheter and a tip adjacent the distal end, wherein said first channel is semi-circular;

a fiber-optic bundle sized to be removably slidably received within said first channel, said bundle having a proximal end and a distal end, and including imaging fibers and light fibers for connection to a camera and a light source, respectively;

connection means at6 the proximal end of said catheter for connecting said fiber-optic bundle to the proximal end of said catheter and for adjustably positioning the distal end of said bundle relative to the distal end of said catheter;

tip deflection means for controllably deflecting said tip of said catheter when the distal end is in the spinal space, wherein said tip has a length dimension of less than about 2.5 cm measured from the distal end of said catheter;

radio-opaque means at the distal ends of said catheter and said fiber-optic bundle for permitting radiographic verification of the relative position of the distal end of said bundle to the distal end of said catheter; and

irrigation means for providing irrigation fluid through said catheter to the distal end of said catheter, wherein said irrigation means includes said first channel in said catheter and means for fluidly connecting said first channel to a source of irrigation fluid, whereby irrigation fluid flows around said fiber-optic bundle when it is disposed within said first channel.

23. The system of claim 22, wherein:

said first channel is semi-circular having a radius, and

said fiber-optic brindle has an outer diameter slightly less than the radius of said first channel.

24. A system for direct visualization of the spinal epidural or intra-discal space comprising:

a disposable flexible catheter sized for percutaneous introduction into the spinal space, said catheter having a proximal end and a distal end for insertion into the spinal space and including a first channel extending along the entire length of the catheter and a tip adjacent the distal end;

a fiber-optic bundle sized to be removably slidably received within said first channel, said bundle having a proximal end and a distal end, and including imaging fibers and light fibers for connection to a camera and a light source, respectively;

connection means at the proximal end of said catheter for connecting said fiber-optic bundle to the proximal end of said catheter and for adjustably positioning t6he distal end of said bundle relative to the distal end of said catheter, wherein said connection means includes;

clamp means for clamping said fiber-optic bundle; and

means for adjusting the length distance between the distal end of said catheter and said clamp means, wherein said means for adjusting includes;

a first housing attached to the proximal end of said catheter and defining a bore for slidably receiving said fiber-optici bundle therethrough,

a second housing connected to said clamp means and defining a bore for receiving said fiber-optic bundle therethrough, and

a threaded post on one of said first and second housing and a mating threaded bore defined in the other of said first and second housing, whereby said threaded post is adjustably threaded into said threaded bore to adjust the length distance between the distal end of said catheter and said clamp means; and

tip deflection means for controllably deflecting said tip of said catheter when the distal end is in the spinal space.

25. The system of claim 24, wherein said connection means further includes rotation means for rotating said fiber-optic bundle relative to said catheter.

26. The system of claim 25, wherein said rotation means includes:

a third housing attached to said clamp means and defining a bore for receiving said fiber-optic bundle therethrough; and

means for rotatably mounting said third housing on said second housing to permit relative rotation between the housings.

27. An apparatus for controlling the viewing angle of an endoscope for direct visualization of the spinal epidural and intra-discal space, the endoscope being formed of a flexible catheter having a bendable tip and a fiber-optic bundle extending therethrough to the tip, the apparatus comprising:

a deflection wire having a first end and a second end and having a first portion adjacent said first end disposed outside the catheter and a second portion between said first portion and said second end insertable through the catheter;

means for securing said second end of said deflection wire to the catheter adjacent the tip thereof;

means for moving the catheter in a first direction from the proximal end toward the tip of the catheter, wherein said means for moving includes means for limiting movement of the catheter in said first direction relative to, said means for restraining to thereby control the amount of deflection of the tip; and

means for restraining said first end of said deflection wire against movement in said first direction as the catheter is moved in said first direction, wherein said means for restraining includes;

an elongated housing defin ing a cavity therein, said housing having openings at its ends for slidably receiving the catheter therethrough;

a sleeve within said cavity and slidably disposed about the catheter;

means for connecting said first end of said deflection wire to said sleeve; and

said housing further defining a stop surface in said cavity for restraining movement of said sleeve in said first direction;

whereby said deflection wire is placed in tension as it is pulled at its second end by the catheter to thereby cause the tip to deflect in the direction of said means for securing.

28. The system of claim 27, wherein said means for limiting movement includes:

a first stop connected to the catheter and slidably disposed within said cavity; and

a pin affixed to said housing and projecting into said cavity between said first stop and said sleeve,

whereby said first stop contacts said pin when the catheter is moved in said first direction.

29. The system of claim 28, wherein initial contact between said sleeve and said stop surface defines a first position and initial contact between said first stop and said pin defines a second position so that displacement of said catheter between said first position and said second position will result in tip deflection of between 0°

and about 9°

.

30. The system of claim 28, wherein said means for limiting movement further includes a second stop connected to the catheter and slidably disposed within said cavity between said pin and said sleeve, whereby said second stop contacts said pin when the catheter is moved in a direction opposite said first direction.

31. An endoscope for direect visualization of the spinal epidural and intra-discal space having a disposable component and a reusable optical component comprising:

a flexible disposable catheter sized for percutaneous introduction into the spinal space, said catheter having a proximal end and a distal end for insertion into the spinal space and including a first channel extending along the entire length of the catheter;

a fiber-optic bundle sized to be removably slidably received within said first channel, said bundle having a proximal end and a distal end, and including imaging fibers and light fibers for connection to a camera and a light source, respectively;

connection means at the proximal end of said catheter for connecting said fiber-optic bundle to the proximal end of said catheter, for rotating said bundle relative to said catheter, and for adjustably positioning the distal end of said bundle relative to the distal end of said catheter, said connection means including;

clamp means for clamping said fiber-optic bundle;

rotation means for rotating said fiber-optic bundle relative to said catheter; and

means for advancing and retracting the distal end of said catheter with respect to said clamp means; and

irrigation means for providing irrigation fluid through said catheter to the distal end of said catheter.

32. The system of claim 32, wherein said means for advancing and retracting includes:

a first housing attached to the, proximal end of said catheter and defining a bore for slidably receiving said fiber-optic bundle therethrough;

a second housing connected to said clamp means and defining a bore for receiving said fiber-optic bundle therethrough; and

a threaded post on one of said first and second housing and a mating threaded bore defined in the other of said first and second housing, whereby said threaded post is adjustably threaded into said threaded bore to adjust the length distance between the distal end of said catheter and said clamp means.

33. The system of claim 32, wherein said rotation means includes:

a third housing attached to said clamp means and defining a bore for receiving said fiber-optici bundle therethrough; and

means for rotatably mounting saiid third housing on said second housing to permit relative rotation between the housings.

34. A method for direct visualization of the spinal epidural and intra-discal space comprising the steps of:

percutaneously inserting an endoscope formed of a flexible catheter with a fiber-optic bundle having both imaging and light fibers slidably disposed therein, the catheter having a deflectable tip unrelated to the fiber-optic bundle, and the fiber-optic bundle being connected to a light source and camera;

advancing the catheter into the spinal space;

keeping the fiber-optic bundle retracted within the catheter until the catheter tip reaches the region to be visualized;

then extending the fiber-optic bundle relative to the catheter until the viewing end of the bundle is adjacent the end of the catheter; and

radiographically verifying the position of the viewing end of the fiber-optic bundle relative to the end of the catheter.

36. The method for direct visualization of the spine according to claim 34, further comprising the step of deflecting the catheter tip to vary the viewing angle of the viewing end of the fiber-optic bundle within the spinal space.

35. A method for direct visualization of the spinal epidural and intra-discal space comprising the steps of:

percutaneously inserting an endoscope formed of a flexible catheter with a fiber-optic bundle having both imaging and light fibers slidably disposed therein, the catheter having a deflectable tip unrelated to the fiber-optic bundle, and the fiber-optic bundle being connected to a light source and camera;

advancing the catheter into the spinal space;

keeping the fiber-optic bundleiretracted within the catheter until the catheter tip retches the region to be visualized;

then extending the fiber-optic bundle relative to the catheter until the viewing end of he bundle is adjacent the end of the catheter;

radiographically verifying the position of the viewing end of the fiber-optic bundle relative to the end of the catheter; and

rotating the fiber-optic bundle relative to the catheter to vary the view orientation through the viewing end of the fiber-optic bundle.

37. A method for direct visualization of the spinal epidural and intra-discal space comprising the steps of:

percutaneously inserting an endoscope formed of a flexible catheter with a fiber-optic bundle slidably disposed therein, the catheter having a deflectable tip and the fiber-optic bundle being connected to a light source and camera;

advancing the catheter into the spinal space;

keeping the fiber-optic bundle retracted within the catheter until the catheter tip reaches the region to be visualized;

then extending the fiber-optic bundle relative to the catheter until the viewing end of the bundle is adjacent the end of the catheter;

radiographically verifying the position of the viewing end of the fiber-optic bundle relative to the end of the catheter;

deflecting the catheter tip to vary the viewing angle of the viewing end of the fiber-optic bundle within the spinal space; and

rotating the fiber-optic bundle relative to the catheter with the tip deflected to vary the view orientation through the viewing end of the fiber-optic bundle.

38. A method for direct visualization of the spinal epidural and intra-discal space comprising the steps of:

percutaneously inserting an endoscope formed of a flexible catheter with a fiber-optic bundle slidably disposed therein, the catheter having a deflectable tip and the fiber-optic bundle being connected to a light source and camera;

advancing the catheter into the spinal space;

keeping the fiber-optic bundle retracted within the catheter until the catheter tip reaches the region to be visualized;

then extending the fiber-optic bundle relative to the catheter until the viewing end of the bundle is adjacent the end of the catheter;

radiographically verifying the position of the viewing end of the fiber-optic bundle relative to the end of the catheter;

deflecting the catheter tip to vary the viewing angle of the viewing end of the fiber-optic bundle within the spinal space; and

rotating the catheter within the spinal space with the tip deflected to further vary the viewing angle.